Re: Request for Information Regarding the President’s Council of Advisors on Science and Technology (PCAST) Report Entitled “Realizing the Full Potential of Health Information Technology To Improve Healthcare for Americans: The Path Forward”

Dear Mr. Posnack:

The American Clinical Laboratory Association (ACLA) is pleased to have this opportunity to submit our comments on the President’s Council of Advisors on Science and Technology (PCAST) Report entitled, “Realizing the Full Potential of Health Information Technology to Improve Healthcare for Americans: the Path Forward.” ACLA is an association representing clinical laboratories throughout the country, including local, regional, and national laboratories. As the primary providers of clinical laboratory services throughout the country, our members would be impacted provided PCAST’s policy recommendations were ultimately implemented. The following comments represent our latest thinking on a few of the issues raised in the PCAST report.

The implementation of metadata-tagged data elements incorporating patient privacy preferences may be problematic for clinical laboratories. First, as indirect providers, clinical laboratories typically do not have contact with patients. To the extent that clinical laboratories would be required to tag data elements with patient privacy preferences, they are generally not in a position to do so. Second, even if metadata tagging is accomplished through middleware or some other methodology not involving intervention by the clinical laboratory, it is possible, depending on how patient privacy preferences are expressed and implemented, that data exchanges to and from clinical laboratories that are legally permissible or required could be blocked. Many unintended and harmful consequences could potentially result.

The Federal government needs to coordinate and sequence its health IT and Health Insurance Portability and Accountability Act (HIPAA) initiatives to reduce the burdens (including cost) on providers facing multiple such initiatives at the same time. Meaningful use of electronic health records (EHRs), a transition to the International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10), and conversion to a universal exchange language with metadata tagged data elements cannot be achieved simultaneously. Furthermore, PCAST has not adequately addressed the cost of making the changes it is proposing, and does not appear to appreciate the implications of such costs for providers such as clinical laboratories.

As outlined above, we have a few concerns with the PCAST report’s policy recommendations. However, if the Office of the National Coordinator (ONC) decides to move forward and implement these policy changes, ACLA provides the following recommendations. An American National Standards Institute (ANSI) accredited standards organization, Health Level Seven (HL7), has already established the version 3.0 standard that utilizes XML and the capability to tag data elements. Rather than working on a separate standards implementation, PCAST should provide input to HL7 to ensure that HL7 considers the views of PCAST as well as all of the affected industry stakeholders. The changes contemplated by HL7 version 3.0 are material, will require virtually complete system rewrites, will be extremely costly to test and implement, and will not be entirely backwardly convertible with previous standards versions. Therefore, an appropriate time frame of at least 5 years from adoption of the standard by ONC would be necessary for implementation, clarification of the obligations of indirect providers such as laboratories with regard to the use of the metadata, and to enable all stakeholders (including EHR vendors) to transition to this new standard. In order to ensure adoption, it’s critical that any new standard become a component of Meaningful Use Certification Criteria.

In closing, we appreciate the opportunity to submit our comments on the PCAST report. If you have any questions or need any further information, please do not hesitate to contact us.